Telemedicine With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— METSZI  

Official title:

Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117580
• Other study ID #: TMED_METSZI_001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2021
• Source: Szeged University
• Contact: István Kósa, MD, Ph.D.
• Phone: +36 70 320 1192
• Email: office.prevmedicina[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.

Description:

The patients are using mobile phone-based nutrition diary with heart rate monitoring watch (including activity meter) connected to a mobile phone with bluetooth technology worn on a wrist. These devices, and the weight scale, blood pressure monitor are connected with bluetooth to an IT system, that transmits and displays data from these devices. the patients are using the devices during 3 months, and get instructions about lifestyle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 18 years and 75 years
• Presence of at least three of the following five risk factors (Metabolic Syndrome ATP

III Criteria):

1. waist width above 102 cm in men and 88 cm in women

2. treated diabetes or blood sugar above 5.6 mmol / l

3. treated hypertension or spontaneous blood pressure = 130/85 mmHg

4. fibrate treatment or triglyceride levels above 1.7 mmol / l

5. blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women

Exclusion Criteria:

• Low level of physical activity (less than 30 minutes a day)
• IT proficiency at least for basic use of mobile phones (answering / making voice calls).
• For women with childbearing potential, by definition, all women who are able to conceive physiologically use dual contraception
• Signing an informed consent.
• The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.

Related Conditions & MeSH terms

• Life Style
• Metabolic Syndrome
• Syndrome

Intervention

Device:
• telemedicine lifestyle guidance
Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of abdominal circumference	To investigate the effect of telemedicine-assisted lifestyle intervention on anthropometric parameters, with particular reference to the reduction of abdominal circumference in patients with metabolic syndrome.	3 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.	The safety of the device system	3 months
Secondary	Impact of the system to the cardiovascular risk	In patients with metabolic syndrome, high cardiovascular risk, the impact of complex lifestyle interventions initiated in different environments and then telemedicine, including lifestyle and physical activity, on the known cardiovascular risk factors and functional indicators	3 months